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Swedish Match USA, Inc., MRTP Applications

On November 7, 2024, the FDA issued modified risk granted orders to Swedish Match USA, Inc. (previously known as Swedish Match North America, Inc.), for the following snus smokeless tobacco products to continue to be marketed as MRTPs with the authorized claim, "Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis."

  • General Loose
  • General Dry Mint Portion Original Mini
  • General Portion Original Large
  • General Classic Blend Portion White Large-12ct
  • General Mint Portion White Large
  • General Nordic Mint Portion White Large-12ct
  • General Portion White Large
  • General Wintergreen Portion White Large

This is the first renewal of modified risk granted orders issued by FDA. These modified risk granted orders issued by FDA are specific to the above-mentioned products and expire November 7, 2032. These products were originally authorized for marketing in the U.S. via the premarket tobacco product application pathway in 2015. In October 2019, the products were then authorized to be marketed as modified risk tobacco products. Those 2019 orders permitting marketing of General Snus products as modified risk tobacco products were valid for 5 years.

Updates to Application

  • On November 30, 2023, FDA filed for scientific review renewal modified risk tobacco product (MRTP) application submitted by Swedish Match USA, Inc. for the General Snus products. The original modified risk granted orders were valid for a term of five years from the date of issuance. To continue marketing an MRTP with the modified risk claim after the term of an order, FDA must issue a renewal authorization after making the determination that the requirements in section 911 of the Federal Food, Drug, and Cosmetic Act continue to be met. Renewal applications may cross-reference an applicant’s original MRTP application as well as postmarket annual reports submitted in accordance with the order requirements for both the premarket tobacco application (PMTA) and MRTP authorizations. Annual reports for MRTPs contain the results from the postmarket surveillance and studies that all companies are required to conduct as part of a modified risk granted order.
  • On June 26, 2024, FDA held a TPSAC meeting to discuss these renewal applications.
  • On July 3, 2024, FDA reposted the following files:
  • On July 15, 2024, FDA reposted Annual Reports Part 8.
  • On November 7, 2024, FDA renewed the modified risk granted orders to Swedish Match USA Inc., for the General Snus products.

Public comments on these applications were submitted to docket FDA-2014-N-1051-0941 on regulations.gov. See the Modified Risk Orders webpage for order letters and decision summaries relevant to these actions.

Please sign up to receive email alerts when materials from any MRTP applications under scientific review have been posted. The latest set of application materials from Swedish Match USA, Inc. were made available on July 15, 2024.

Materials and Related Documents

Temporary Compliance Waiver: The linked files may not be fully accessible to readers using assistive technology. We regret any inconvenience that this may cause. In the event you are unable to read these documents or portions thereof, please email AskCTP@fda.hhs.gov or call 1-877-287-1373.

Additional materials related to the actions include:

Swedish Match USA, Inc. MRTP Application Renewal – updated November 7, 2024

Swedish Match USA, Inc. MRTP Application – Authorized on Oct. 22, 2019

  • FDA Decision Summary (PDF – 5 MB) – posted December 14, 2016
  • Summary of Applications (PDF – 32 MB) (posted August 27, 2014; updated January 16, 2019
  • FDA initially redacted certain harmful and potentially harmful constituents (HPHC) information on pp. 517-544 (internal document pagination), which were later made publicly available. The current version reflects the removal of these redactions.

 

* These ZIP files include several individual files. Depending on your Internet connection speed and other factors, it may take a few minutes or up to several hours to download a ZIP file completely.

Note: We are required by section 911(e) of the Federal Food Drug & Cosmetic Act, as amended by the Tobacco Control Act, to make modified risk tobacco product (MRTP) applications available to the public (except for matters in the application that are trade secrets or otherwise confidential commercial information) and to request comments on the information contained in the applications and on the label, labeling, and advertising accompanying the applications. Please visit our Modified Risk Tobacco Products web page for more information.

Additional Resources

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